Akiram Therapeutics is set to present key preclinical data on its lead drug candidate, 177Lu-AKIR001, at the Targeted Radiopharmaceuticals Summit Europe 2024 in Amsterdam. The data supports the initiation of first-in-human trials for 177Lu-AKIR001 in Q1 2025. The drug is a targeted radiopharmaceutical designed to combat cancers expressing the CD44v6 marker, which is often linked to aggressive tumor behavior.
Preclinical Efficacy and Trial Design
Dr. Marika Nestor, CEO of Akiram Therapeutics and Professor at Uppsala University, will present the data, highlighting the therapeutic efficacy of 177Lu-AKIR001 in preclinical tumor models. The presentation will cover toxicology studies and successful GMP labeling, which are critical components of the IND-enabling data package. The presentation will also address strategic considerations for designing effective clinical trials, focusing on the transition from preclinical research to clinical trials and emphasizing the role of targeted radiopharmaceuticals in addressing significant unmet needs in oncology.
177Lu-AKIR001: Targeting CD44v6
177Lu-AKIR001 combines lutetium-177, a radioactive isotope, with a molecule that targets CD44v6, a cancer marker. Preclinical studies suggest that 177Lu-AKIR001 has the potential to be a first-in-class radiopharmaceutical therapy for cancers with high CD44v6 expression. Akiram Therapeutics utilized antibody phage display and affinity maturation to develop the targeted therapy.
Clinical Trial Plans and Potential Indications
Clinical trials are scheduled to begin at Karolinska University Hospital in Sweden in early 2025. According to Prof. Nestor, 177Lu-AKIR001 could become a first-in-class treatment for various cancer types, including anaplastic and iodine-refractory thyroid cancer, head and neck squamous cell carcinoma, and non-small cell lung cancer. These indications represent areas of significant unmet medical need, particularly in cases where conventional treatments have proven ineffective.
